The influence of small airway inflammation on symptoms in patients with asthma

Phase 1

• Conditions: Asthma; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-000357-12-NL
• Lead Sponsor: Stichting Longgeneeskunde Fryslan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-24
• Last Update Posted: 13 June 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Adults with symptoms compatible with asthma or COPD
-Non-smoking, (=10 packyears)
-BMI =30
-ICS (=500 mcg fluticasone equivalent) or daily oral corticosteroids combined with LABA or other controller for at least 6 months.
-Stable disease, no exacerbations in last 4 weeks
-FEV1/FVC =80% of predicted
-MPT induced dynamic hyperinflation: ? IC =-10%
-CPET induced dynamic hyperinflation: ? IC =-10%

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

-Concurrent respiratory diseases
-Clinically significant cardiovascular disease
-Pregnant or breastfeeding women
-History of hypertension, diabetes mellitus, menorrhagia, psychiatric diseases, idiopathic thrombocytopenic purpura, ulcus ventriculi, ulcus duodeni, infectious disease, infection after administration of live or live, attenuated vaccines.
-Hypersensitivity to any components of triamcinolon acetonide

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified